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The Delta III Pro Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Pro Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.
The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table: .
• Control Desk/Image Storage (UIMS). .
  The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.
  The therapy and X-ray C-arm house the shock wave source ("EMSE") and the complete X- ray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, a flat panel image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.
  The Delta III Pro's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.
  The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-rav control and image handling.

The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of typical AI/ML device performance studies (e.g., sensitivity, specificity, accuracy against a ground truth).

Instead, the document is a 510(k) submission for a Delta III Pro Lithotripter, which is a medical device for fragmenting urinary tract stones. The submission focuses on demonstrating substantial equivalence to a predicate device (Dornier Delta III Lithotripter, K201074) based on minor modifications.

The "Performance Data" section describes compliance with electrical safety, electromagnetic compatibility, radiation protection, safety of lithotripsy equipment, safety and performance of x-ray equipment, and usability engineering standards (IEC standards), as well as software verification and validation. These are engineering and regulatory compliance criteria, not performance metrics like sensitivity or specificity for a diagnostic AI.

Here's a breakdown of why the requested information for acceptance criteria and related study details cannot be found in the provided text:

• This is not an AI/ML device in the context of diagnostic performance: The device is a lithotripter, which physically breaks down stones. Its performance is measured by its safety, efficacy in stone fragmentation, and compliance with various engineering standards, not by diagnostic accuracy.
• The "Performance Data" section refers to regulatory compliance and non-clinical testing: "Non-clinical functional testing successfully passed and met all design requirements" and compliance with IEC standards are mentioned. This refers to engineering verification and validation, not a clinical study comparing its diagnostic performance against a ground truth with human experts.
• No mention of human readers, AI assistance, or diagnostic metrics: The text does not discuss human interpretation of images/data, AI algorithms for analysis, or metrics like accuracy, sensitivity, specificity, AUC, etc.

Therefore, many of your specific questions are not applicable to the information provided in this 510(k) summary. I cannot create the table or answer the questions the way they are designed for an AI/ML diagnostic device.

However, I can extract the information that is present regarding "performance" in the context of this device and its submission:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for diagnostic performance, but it lists standards with which the device complies. The "reported device performance" is primarily stated as successful compliance with these standards and established design requirements.

2. Sample size used for the test set and the data provenance
This information is not provided because it's a non-clinical, engineering verification for a physical device, not an AI/ML diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" in the diagnostic sense is established for this type of device.

4. Adjudication method for the test set
Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the diagnostic sense. The "ground truth" for this device would be established engineering specifications, safety standards, and performance benchmarks for stone fragmentation, which are not detailed in this summary.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in that context.

9. How the ground truth for the training set was established
Not applicable.

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The Dornier Nautilus is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Nautilus is an Image Intensified Fluoroscopic X-ray System with a flat panel image receptor system. The Nautilus consists of the following components: an X- ray generator and tube housing, flat panel detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics for the imaging chain.

The Dornier Nautilus is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted under the table on a fixed arm. A flat panel detector is mounted above the patient table. The flat panel used is a Varex model 4343DXV. These Varex 4343 series have been used in similar cleared devices (K192541). The Varex flat panel system uses Cesium lodide as the image scintillator which is identical to that used in the predicate device. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position. The captured images are processed and can be stored in the users DICOM system.

The provided text describes the Nautilus, an image intensified fluoroscopic x-ray system. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

The "Performance Data" section primarily addresses adherence to electrical safety and electromagnetic compatibility (EMC) standards, and software verification and validation. These are crucial for the safety and basic functionality of the device, but they are not the typical performance metrics associated with demonstrating the clinical efficacy or diagnostic accuracy of an imaging system compared to a ground truth or a human reader.

Here's a breakdown of what is and isn't present, based on your request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria Mentioned: The text implicitly states acceptance criteria by listing the standards that the Nautilus was tested against (e.g., IEC 60601-1, IEC 60601-1-2). The "Performance Data" states that "Performance testing confirmed that the Nautilus met the requirements of the following standards."
• Reported Device Performance: The document only reports conformance to these safety and software standards, not specific performance metrics in terms of image quality, diagnostic accuracy, or clinical outcomes. There are no numerical results (e.g., contrast-to-noise ratio, spatial resolution, diagnostic sensitivity/specificity) provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No clinical or diagnostic performance test set is described. The testing mentioned is for electrical safety, EMC, and software, which typically involves engineering tests, not patient data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment for diagnostic performance is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No diagnostic performance test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. The document explicitly states: "Clinical testing is not necessary for the subject system Nautilus, based on the same basic technology as the predicate device and based on existing minor differences." This indicates that an MRMC study or any clinical effectiveness study was not performed or deemed necessary for this 510(k) submission. There is no AI assistance mentioned, so no effect size for human readers with AI vs. without AI assistance can be provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This device is an imaging system (fluoroscopic x-ray system) and not an AI algorithm. Its performance is evaluated fundamentally in conjunction with a human operator / clinician interpreting the images. No standalone algorithm performance is applicable or discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Applicable. No diagnostic ground truth is mentioned. The "ground truth" for the non-clinical tests would be the requirements defined by the referenced international standards for electrical safety, EMC, and software quality.

8. The sample size for the training set

• Not Applicable. As no AI algorithm or diagnostic performance study is described, there's no training set for such a purpose.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of Device Acceptance and Study as Described in the Document:

The Nautilus device's acceptance is based on its substantial equivalence to a predicate device (Dornier Genesis K151485) and its demonstrated conformance to established international standards for:

• Electrical Safety: IEC 60601-1, EN 60601-1-6, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54
• Electromagnetic Compatibility (EMC): IEC 60601-1-2
• Usability: EN 60601-1-6, IEC 62366-2
• Software Verification and Validation: Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern).

The study that "proves the device meets the acceptance criteria" is non-clinical testing (bench testing) against these referenced standards. No clinical studies, human reader studies, or diagnostic performance studies with explicit acceptance criteria (e.g., sensitivity/specificity thresholds) and corresponding test results are provided in this submission document. The rationale provided for not conducting clinical testing is that the device uses "the same basic technology as the predicate device and based on existing minor differences."

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The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology. The Delta III is composed of the following modules: Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment; Patient Table; Control Desk/Image Storage (UIMS).

This document is a 510(k) summary for the Delta III Lithotripter, detailing minor changes to an existing device. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a human-in-the-loop performance evaluation. The information provided primarily consists of engineering and software validation.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

1. Table of acceptance criteria and the reported device performance

The document does not present a formal table of acceptance criteria for clinical performance in the way one might expect for a new diagnostic or AI device. Instead, the "acceptance criteria" are implied by compliance with standards and functional validation tests, with the reported performance being "does not impact the performance" and "equal to or better than the predicate."

2. Sample size used for the test set and the data provenance

The document describes bench testing and standards compliance, not a clinical test set with patient data. Therefore, there is no mention of a "sample size for the test set" in the context of patient data, nor its provenance (country of origin, retrospective/prospective). The tests mentioned are engineering and software validation tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to the submission described. The described tests are about technical performance, safety, and functionality, not about expert interpretation of medical images or patient outcomes. Ground truth in this context would refer to engineering specifications or validated functional requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the submission describes engineering and software validation, not a clinical study requiring adjudication of diagnoses or findings.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or is mentioned. The submission is for minor changes to an existing lithotripter, focusing on hardware component replacements and software updates, not AI integration for improved human reading.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device (Delta III Lithotripter) is a medical device for shock wave lithotripsy. While it includes image processing software (UIMS with AGFA MUSICA), the evaluation described is for the functional performance of these components within the overall system, not a standalone algorithm being evaluated for diagnostic accuracy without human involvement. The AGFA MUSICA software enhances X-Ray image processing, but it's part of the lithotripter system for visual guidance during procedures, not a diagnostic AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the described tests, the "ground truth" would be established by:

• Engineering specifications and regulatory standards: For electrical safety, EMC, radiation protection, and usability.
• Predicate device performance: For the ultrasound image quality and camera image quality, the ground truth for comparison is the performance of the components being replaced.
• Functional requirements: For the UIMS software validation, the ground truth is that the software should perform its intended function (e.g., image processing, PACS connection) without negatively impacting other equipment functions.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these specific validation tests.

8. The sample size for the training set

Not applicable. This submission does not involve a machine learning or AI model that requires a training set in the conventional sense. The UIMS software update involves incorporating the AGFA MUSICA package, which is likely a pre-existing, validated image processing software, not a custom-trained model for this specific application.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set.

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The Delta III Lithotripter is indicated for the fragmentation of urinary tract stones, i.e., renal calyceal stones, renal pelvic stones, and upper ureteral stones.

The Delta III Lithotripter is a modular urological work station designed for extracorporeal shock wave lithotripsy ("ESWL") and for diagnostic and therapeutic procedures usual in urology.

The Delta III is composed of the following modules:

• . Basic Unit with integrated X-ray C-arm and Therapy Arm with camera for Shockwave Treatment;
• Patient Table;
• . Control Desk - Image Processing.

The basic unit contains the power supplies, control unit, power electronics for motor drives, components for shockwave generation, and an integrated Therapy C-arm and an X-Ray C-Arm. The housing can be positioned with its back close to the room wall and has wide side doors for easy service.

The therapy and X-Ray C-arm house the shock wave source ("EMSE") and the complete Xray unit. The X-ray unit consists of the X-ray generator, the X-ray tube, an image receptor system, and a high resolution imaging chain. This provides the imaging to perform the procedures. The C-arms allow for a wide range of movement to facilitate performing urological procedures. The shock wave circuit supplies the shock wave energy needed for the treatment of kidney stones.

The Delta III's urological patient table provides longitudinal, lateral and vertical travel range to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

The image processing system (UIMS) with DICOM 3 capability supports PACS connection and offers complete X-ray control and image handling.

This document describes a 510(k) submission for the Delta III Lithotripter, which is a modification to a previously cleared device. As such, the submission focuses on demonstrating substantial equivalence to the predicate device rather than conducting extensive new clinical studies to establish absolute performance against defined acceptance criteria for a novel device.

Therefore, the typical structure for reporting acceptance criteria and study details for a new device's performance may not be fully applicable here. However, I can extract the information provided regarding the changes and how their safety and effectiveness were addressed.

Here's an analysis based on the provided text, addressing the points you requested where relevant:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., stone free rate, re-treatment rate) for the modified device, as this is a modification to a predicate device. The primary performance demonstration is focused on showing that the changes do not negatively impact safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes tests for compliance with electrical, EMC, radiation, and usability standards, as well as software and hardware verification. These are typically engineering and bench tests, not clinical studies with human subjects in the traditional sense. Therefore, the concept of "sample size used for the test set" for patient data, country of origin, or retrospective/prospective does not apply to the provided performance data. The tests performed are on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The performance data provided is based on compliance with international standards and internal engineering verification, not on expert adjudication of clinical outcomes or images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable, as the tests are for engineering compliance and verification, not for clinical outcomes requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a lithotripter, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical medical device (lithotripter), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the verification tests mentioned (e.g., electrical safety, software functionality), the "ground truth" is defined by the requirements of the applicable international standards (e.g., IEC 60601 series) and the design specifications of the device. For example, for electrical safety, the ground truth is compliance with the specified voltage limits or isolation requirements in the standard. For software, it's meeting the intended function and not introducing errors.

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device and its modifications, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

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Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory for the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy,
• Urology,
• Lithotripsy, ●
• Pulmonology,
• Gastroenterology,
• Gynecology,
• o ENT.
• General Surgery.

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K152591) to include a rounded, ball tip, distal end. The fiber core and cladding for the subject device are made from silica, which is same material used in the predicate device. Additionally, the fiber is manufactured and tested in the identical fashion as the company's predicate device and functions in an equivalent manner.

The medical device described in the document is the "Dornier Medilas H RFID Gentle Flex Laser Fiber," an accessory for the Dornier Medilas H Holmium Laser. This device is a modification of a previously cleared device (K152591), with the primary change being the addition of a rounded, ball-tip distal end.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each functional performance test. The data provenance is also not explicitly stated in terms of country of origin, nor whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The performance tests appear to be engineering/technical evaluations rather than clinical studies requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable or provided, as the tests described are functional performance tests rather than assessments requiring human adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study was mentioned or performed. The studies were non-clinical functional performance tests comparing the modified device to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable as the device is a medical accessory (laser fiber) and not an AI or algorithm-based device.

7. The Type of Ground Truth Used

For the functional performance tests, the "ground truth" was established by comparing the performance characteristics of the modified (subject) device against the established performance characteristics of the predicate device (Dornier Medilas H RFID Laser Fiber - K1525591). These are objective measurements related to physical and optical properties.

8. The Sample Size for the Training Set

This question is not applicable as the device is not an AI or algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as the device is not an AI or algorithm-based device.

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Dornier's Medilas H RFID Laser Fibers are intended to be used as an accessory to the Dornier Medilas H Holmium Laser ("Laser"). This laser is intended for cutting, vaporization, ablation, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Laser is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy,
• . Urology,
• Lithotripsy,
• Pulmonology,
• . Gastroenterology,
• Gynecology,
• ENT,
• General Surgery.

The Medilas H RFID Laser Fiber is a modification to Dornier's currently cleared Dornier Medilas H RFID Laser Fibers (K121938) to include a fiber with a reduced outer diameter. The fiber core and cladding for the subject device are made from silica.

This document is a 510(k) premarket notification for a medical device called "Dornier Medilas H RFID Laser Fiber." It is a request for clearance from the FDA to market a modified laser fiber. The document evaluates the new device against previously cleared predicate devices to demonstrate substantial equivalence, rather than establishing acceptance criteria and conducting a study to prove device performance against those criteria in the context of an AI/algorithm-based diagnostic device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance cannot be provided from this particular document, as it pertains to a different type of device and regulatory submission.

The document contains information primarily related to:

• Device Name: Dornier Medilas H RFID Laser Fiber
• Intended Use/Indications for Use: Used as an accessory to the Dornier Medilas H Holmium Laser for cutting, vaporization, ablation, and coagulation of soft tissue in various medical specialties.
• Technological Characteristics: Similar to predicate devices, made from silica, manufactured and tested in the identical fashion. The key modification is a "reduced outer diameter" of the fiber.
• Performance Data (Nonclinical functional testing):
  • Power transmission testing
  • Durability Stress Testing
  • Eccentricity Testing
  • Visual Inspections
  • These methods were the same as used for the cleared predicate.
• Substantial Equivalence Claim: The device has the same intended use/indications for use, technological characteristics, and principles of operation as predicate devices. The minor difference in outer diameter does not raise new safety or effectiveness concerns, and performance data demonstrates substantial equivalence.

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The Dornier Genesis with Windows 7 is an image intensified, fluoroscopic x-ray system that is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Genesis with Windows 7 is an Image Intensified Fluoroscopic X-ray System. The Genesis with Windows 7 consists of the following components: an x-ray generator and tube housing image detector (flat panel or Image Intensifier), monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.

The provided text describes a Special 510(k) Summary for the Dornier Genesis with Windows 7, an image-intensified fluoroscopic x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance studies in the way you've outlined for an AI/device performance study.

Here's an analysis based on the information provided, highlighting what is and is not present concerning your request:

The core of this document is a 510(k) submission seeking clearance for a modification to an existing medical device. The primary "study" proving the device meets its acceptance criteria is the demonstration of substantial equivalence to a legally marketed predicate device. The acceptance criteria for this type of submission are typically adherence to recognized standards and a demonstration that the changes do not introduce new safety or effectiveness issues.

1. A table of acceptance criteria and the reported device performance

No explicit table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) is provided, nor is there reported device performance in those terms. The "acceptance criteria" here are broad regulatory compliance and substantial equivalence to a predicate device.

The "performance data" section lists recognized testing standards that Dornier MedTech America, Inc. states the device complies with:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes compliance with standards and risk analysis, not a clinical performance study with a specific test set of patient data. The modification is primarily a software platform upgrade (Windows XP to Windows 7), implying that the core imaging hardware's performance characteristics are considered unchanged.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. As there's no mention of a clinical test set for diagnostic performance, there's no discussion of ground truth establishment by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not mentioned or indicated. The device is an imaging system, not an AI-assisted diagnostic tool in the typical sense of generating interpretations or assisting human readers with diagnostic tasks. The change is an operating system upgrade.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of an algorithm is not mentioned or indicated. This is not an algorithmic diagnostic device, but rather an imaging system.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Ground truth for diagnostic performance is not applicable in the context of this 510(k) summary, as it's not a diagnostic algorithm undergoing validation of its diagnostic accuracy. The ground truth for the engineering tests mentioned would be the specified requirements of the standards (e.g., specific measurement readings, functional tests).

8. The sample size for the training set

This information is not provided. This device is not an AI/machine learning product that requires a training set for model development.

9. How the ground truth for the training set was established

This information is not provided. This is not applicable to the device described.

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The Dornier GENESIS II is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Dornier Genesis II is an Image Intensified Fluoroscopic X-ray System. It is intended for use in a wide field of applications, including all general examinations in urology and gynecology, as well as endoscopic and contrast examinations, imaging with radiography and/or fluoroscopy on patients in either the horizontal or vertical position.

The Genesis II consists of the following components: an x-ray generator and tube housing, image intensifier detector, monitors and procedure table. An X-ray cabinet contains system elements such as the X-ray generator, power electronics and electronics for the imaging chain.

The Genesis II is a radiographic and fluoroscopy examination table with the X-ray tube housing mounted over the table on a fixed arm. An image intensifier is mounted underneath the patient table. While the X-ray tube and detector are fixed in their positions relative to each other when the system is in use, the table top and X-ray/detector unit can be moved in a variety of planes to position the patient in the desired imaging position.

The provided text describes the 510(k) premarket notification for the Dornier MedTech America, Inc. Genesis II device, an Image Intensified Fluoroscopic X-ray System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific quantitative acceptance criteria.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: The document states, "a board certified radiologist evaluated a number of sample images obtained using the Genesis II." A specific numerical sample size is not provided.
• Data Provenance: The origin of the sample images (e.g., country of origin) and whether the data was retrospective or prospective is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: "a board certified radiologist" — this suggests one expert.
• Qualifications of Experts: The expert was a "board certified radiologist." No further detail (e.g., years of experience) is provided.

4. Adjudication method for the test set

• "a board certified radiologist evaluated... and determined..." This indicates that the evaluation was performed by a single expert. There is no mention of an adjudication method involving multiple experts to establish ground truth or resolve discrepancies, as only one expert is noted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. The document describes the evaluation of image quality of the device itself, not the performance of human readers with or without AI assistance. This device is an imaging system, not an AI-based diagnostic tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This question is not applicable as the Genesis II is an X-ray imaging system, not an algorithm or AI device that performs diagnoses independently. The evaluation described is for the diagnostic quality of the images produced by the hardware, which would then be interpreted by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for the image quality assessment was established through expert opinion/evaluation by a single board-certified radiologist, who determined if the images were of "acceptable diagnostic quality." There is no mention of an objective reference standard like pathology or outcomes data.

8. The sample size for the training set

• The document implies that the device (Genesis II) itself was designed and verified against established engineering and safety standards, and its image intensifier technology is based on previously cleared devices. It does not describe a "training set" in the context of an algorithm or AI model. Therefore, this question is not applicable for this type of device submission.

9. How the ground truth for the training set was established

• As the concept of a "training set" for an algorithm is not applicable to this device, the establishment of its ground truth is not relevant in this context. The device's "training" in a functional sense would be its design, manufacturing processes, and adherence to established technical standards, as well as the prior clearance of its component technologies.

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The Uropulse is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Uropulse is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy .
• Urology .
• Lithotripsv
• Pulmonology
• Gastroenterology
• Gynecology
• ENT
• General Surgery

The Dornier Medilas D Uropulse Laser is a solid-state Holmium YAG Laser. The laser emits laser radiation in the invisible wavelength range of 2080 nm in either a continuous-wave or pulsed mode, which is absorbed primarily by water, with an average penetration depth of approximately 400μm (0.4mm). Due to the application-dependent optimization of the pulse time of 350 microseconds, the Uropulse can be used in various medical applications including breaking up stones, cutting tissue, tissue ablation, coagulation and vaporization.
The laser is microprocessor-controlled utilizing a watchdog-monitored microprocessor and operates with an internal cooling system and a heat exchanger. The bottom of the housing serves as a tank for cooling water and, at the same time, a base for the laser unit. A cooling circuit conducts away heat that is generated by the laser pump lamp. Water heated by the laser pump is conducted out of the cavity and into the stainless steel cooler. Following cooling, it is returned to the tanks.
A graphic control panel regulates and displays the operating parameters, application modes, time functions, system status and messages to the User. The control panel consists of a display with integrated touch screen panel applications to control the functions of the laser.
The laser light emission is transmitted to the application site by a sterile fiber optic delivery system (fiber cable) with a SMA 905 connector. Laser energy is transmitted through the fiber to the application site by depressing a foot pedal. The foot pedals, both the wired and wireless, are water- proof and explosion-proof. Various fiber sizes can be utilized depending on the application.
The laser pulse energy at the distal end of the fiber lies within the range of 200-3500mJ. The pulse frequency can be adjusted in 0.2Hz increments between 3 and 20 HZ. The Uropulse contains an aiming beam at a wavelength of 532nm at the maximum power aperture of 1mW. The device employs a Class IV (4) laser pursuant to 21 CFR 1040 and IEC/EN 60825-1.

The provided text is a 510(k) summary for a medical device called "Medilas H Uropulse," a Holmium: Yttrium Aluminum Garnet (HO:YAG) Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed study.

Therefore, many of the requested categories related to acceptance criteria and specific study results (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth for training/test sets) are not applicable or available in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable: This submission is for a Special 510(k) based on device modifications and substantial equivalence, not a clinical trial proving performance against a specific test set. The submission does not describe a test set or data provenance in the way clinical studies would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: No test set or ground truth establishment by experts is described in this regulatory submission.

4. Adjudication method for the test set

• Not Applicable: No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable: This device is a laser system, not an AI diagnostic tool. MRMC studies are irrelevant here.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable: This is a laser surgical instrument, not an algorithm. Its performance is inherent in its physical operation, not an algorithmic output.

7. The type of ground truth used

• Not Applicable: For this type of device and submission, "ground truth" as it pertains to diagnostic accuracy (like pathology or outcomes data for AI) is not relevant. The "truth" being established is that the modified device performs safely and effectively similarly to its predicates. This is typically supported by engineering testing, bench testing, and comparison of specifications rather than
  clinical ground truth derived from expert consensus or pathology on a patient cohort.

8. The sample size for the training set

• Not Applicable: This is a hardware laser system, not a machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

• Not Applicable: As above, this is not an AI device and does not have a "training set" with associated "ground truth" in that context.

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The Solvo is intended to be used for cutting, vaporization, and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopes), or for open surgery for contact or non-contact surgery with or without a handpiece for use in incision/excision, vaporization, ablation and coagulation of soft tissue. The Solvo is indicated for use in medicine and surgery, in the following medical specialties:

• Arthroscopy .
• Urology
• Lithotripsy
• Pulmonology
• Gastroenterology
• Gynecology
• ENT .
• General Surgery

The Solvo is a modification to Dornier's Medilas H20 Laser K061455.

The provided text describes a 510(k) summary for the Medilas H Solvo Holmium Laser, which is a modification of an existing device. This document is a regulatory submission for substantial equivalence and does not contain any information regarding clinical studies or device performance metrics against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, or training set details.

The document primarily focuses on:

• Identifying the device and its manufacturer.
• Classifying the device.
• Identifying the predicate device.
• Stating the intended use and indications for use.
• Asserting substantial equivalence to the predicate device based on design specifications and technological characteristics, without presenting any new performance data.

The FDA's letter (Sections 2 and 3) acknowledges the 510(k) submission and confirms that the device is substantially equivalent for the stated indications for use, subject to general controls. It does not refer to any performance data or clinical studies in this context.

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